A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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An Open-label and Single Arm Study of ATG-010 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
1 other identifier
interventional
60
1 country
18
Brief Summary
This is an open-label, single arm, and registered study of ATG-010 in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2020
Typical duration for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2019
CompletedFirst Posted
Study publicly available on registry
June 20, 2019
CompletedStudy Start
First participant enrolled
April 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedResults Posted
Study results publicly available
February 7, 2025
CompletedFebruary 7, 2025
April 1, 2024
3.1 years
June 18, 2019
April 28, 2024
February 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
ORR
ORR is defined as the proportion of patients who achieve either complete response (CR) or partial response (PR) according to the revised criteria for response assessment of lymphoma (2014 Lugano criteria: A complete metabolic response requires Score 1, 2, or 3 with or without a residual mass on 5PS(5-point scale using PET-CT). A PR requires a decrease by more than 50% in the sum of the product of the perpendicular diameters of up to six representative nodes or extranodal lesions.)
12 months
Secondary Outcomes (1)
PFS
12 months
Study Arms (1)
ATG-010
EXPERIMENTALEnrolled patients will be treated with a fixed dose, 60 mg of ATG-010.
Interventions
Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle.
Eligibility Criteria
You may qualify if:
- The patient must provide informed consent form (ICF) prior to the first screening procedure.
- Age ≥18 years.
- ECOG performance status of ≤ 2.
- Patients should have estimated life expectancy of \>3 months at study entry.
- Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma).
- Patients must have received at least 2 but no more than 5 previous systemic regimens for the treatment of their de novo or transformed DLBCL.
- Documented clinical or radiographic evidence of progressive DLBCL prior to dosing.
- Patients must have measurable disease per the revised criteria for response assessment of lymphoma (Cheson, 2014).
- Patients must not be eligible for high-dose chemotherapy with autologous stem cell transplantation rescue.
You may not qualify if:
- Patients who are pregnant or lactating.
- DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (Hodgkin's lymphoma +NHL), or DLBCL transformed from diseases other than indolent NHL or Richter's.
- Primary mediastinal (thymic) large B-cell lymphoma.
- Known central nervous system lymphoma or meningeal involvement.
- Patients whose most recent systemic anticancer therapy include radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy other than glucocorticoids \< 6 weeks prior to first dose of study drug.
- Patients who have not recovered to Grade ≤ 1 clinically significant adverse events, or to their baseline, from their most recent systemic anti-DLBCL therapy.
- Patients with active graft-versus-host disease after allogeneic stem cell transplantation. At least 4 months must have elapsed since completion of allogeneic stem cell transplantation.
- Major surgery within 2 weeks of first dose of study treatment of ATG-010.
- Any life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.
- Active hepatitis B virus or hepatitis C virus infection.
- Known human immunodeficiency virus infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Anhui Province Cancer Hospital
Hefei, Anhui, 230000, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Chongqing Universtity Cancer Hospital
Chongqing, Chongqing Municipality, 400000, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Hubei Cancer Hospital
Wuhan, Hubei, 430000, China
Wuhan Union Hospital
Wuhan, Hubei, 430022, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The First Affilate Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin blood research institute
Tianjin, Tianjin Municipality, 300052, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
Cancer Hospital of the University of the Chinese Academy of Sciences
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Yumei Tang
- Organization
- Antengene Corporation
Study Officials
- STUDY DIRECTOR
Bingshan Liu, MD
Medical Monitor
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2019
First Posted
June 20, 2019
Study Start
April 9, 2020
Primary Completion
May 31, 2023
Study Completion
December 1, 2023
Last Updated
February 7, 2025
Results First Posted
February 7, 2025
Record last verified: 2024-04